DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. DRAFT FOR DISCUSSION PURPOSES ONLY MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: November 9, 1994 RE: Questions to Consider in the Context of Memo on Total Body Irradiation Research on Radioresistant Cancers, 1940-74 1. Did the Department of Defense's military interest in the effects of total-body irradiation on healthy persons result in the inappropriate exposure of ill persons to potentially harmful radiation? 2. Once it was determined that the DOD could not experiment with total-body irradiation on healthy persons, was the DOD justified in pursuing this line of inquiry with people who were ill: a. on scientific grounds? b. on ethical grounds? 3. What were the DOD's obligations with respect to the ethics of the work done by its medical contractors, including the underlying clinical practices? 4. What ethical concerns are raised when physicians use money to support clinical or research activities, when the funder's intent is to address questions other than medical care or medical science? 5. Would these experiments be permitted today? a. Was the harm/benefit ratio acceptable? b. Were the consent procedures adequate? c. Were the subject selection criteria appropriate? d. At what point do preliminary data about mortality (or other negative outcomes) require stopping of the project or explicit disclosure of such risk?